Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT03964818
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010000', 'term': 'Osteitis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of treatment failures at Day 45 after surgery', 'timeFrame': 'at 45 days', 'description': 'Primary outcome is the number of patients presenting treatment failure during a 45-day follow-up period after surgery, defined as the presence of dehiscence, and/or local signs of inflammation, and/or sepsis, and/or additional antibiotic treatment.'}], 'secondaryOutcomes': [{'measure': 'Risk factors associated with the occurrence of treatment failure at Day 45 after surgery', 'timeFrame': 'at 45 days', 'description': "Risk factors among patients' baseline characteristics, biological or microbiological analysis, or antibiotic treatments, significantly associated with the occurrence of treatment failure during a 45-day follow up period after surgery."}, {'measure': 'Impact of antibiotic treatment duration on the occurrence of treatment failure at Day 45 after surgery', 'timeFrame': 'at 45 days', 'description': 'Comparison between 7 days and 10 days of antibiotic treatment duration on the number of patients presenting treatment failure at Day 45 after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteitis', 'flap surgery', 'short-course antibiotics'], 'conditions': ['Pressure-related Osteitis']}, 'descriptionModule': {'briefSummary': "Pressure ulcers associated with osteitis are frequent among patients with spinal cord injury (SCI), and optimal management is not well known. In a French referral center, debridement and flap coverage surgeries performed simultaneously are followed by a short antibiotic treatment targeting the bacteria involved. The aim of the study is to evaluate patient's outcome at Day 45 after surgery, and identify factors associated with failure.", 'detailedDescription': "Spinal cord injured (SCI) population is subject to pressure ulcers because of numerous risk factors: neurological disorders, which reduce ability to mobilization, potential, undernutrition, confinement to bed, and vascular disorders promoting the lesions.\n\nDespite the attention given to preventative strategies, in this population, prevalence of pressure ulcers varies from 10% to 30%, with an annual incidence rates range ranging from 20%-% to 31%.\n\nIn community-dwelling SCI population, stages III and IV pressure ulcers account for 25% of total ulcers observed.\n\nThey are a major cause of healthcare centers admissions or homecare nursing. Duration of ulcers could vary from 1 week to 3 years.\n\nAlso, their occurrence is associated with potential repeated hospitalizations and with a longer length of stay. Furthermore, pressure ulcers are an important economic burden to the health care system.\n\nPressure ulcers interfere with the patient's physical, psychological, and social well-being and impact the overall quality of life.\n\nOver recent years, an increased pressure ulcer prevalence has been reported. Therefore, they are frequent and their clinical spectrum is wide. They also readily become superinfected and can lead to sepsis.\n\nEstablishing the diagnosis of osteomyelitis in this setting is challenging, and physicians often struggle with the appropriate therapeutic management.\n\nA recent review did not find evidence of benefit of antibacterial therapy in osteomyelitis associated with pressure ulcers without concomitant surgical debridement and wound coverage. But this type of management remains controversial.\n\nIn a French referral center, patients with pressure ulcer-related osteitis benefit from a one-stage surgical management with bone shaving and flap covering, followed by a probabilistic post-operative antibiotic treatment, secondarily adapted to peroperative samples, for a total duration of effective antibiotic treatment of 7 or 10 days.\n\nThus, the investigators aim to evaluate this original strategy, identify risk factors for failure, and focus on the role of antibiotic treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18 years;\n* Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment.\n\nExclusion Criteria:\n\n* Patient \\< 18 years;\n* Patient under under guardianship;\n* Patient with concomitant infections;\n* Patient having declare his opposition to study participation.'}, 'identificationModule': {'nctId': 'NCT03964818', 'acronym': 'SCAR', 'briefTitle': 'Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pressure Sore-related Osteitis Treated by Flap Coverage and Short Antibiotic Regimen', 'orgStudyIdInfo': {'id': '19ADH-SCAR'}}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Hauts-de-Seine', 'country': 'France', 'facility': 'Infectious Diseases Department - Raymond Poincaré University Hospital', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Aurélien DINH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Infectious Diseases Department - Raymond Poincaré University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}